Role & Responsibilities
Opportunity : The R&D Verification Senior Scientist will line manage a small team of technical staff dedicated to the development and execution of verification test methods.
They will be responsible for delivering verification data sets and reports required to verify the performance claims of products.
They will coordinate the delivery of verification data sets and reports required to verify the performance claims of LumiraDx products.
Key areas of responsibility :
Lead the development of significant project activities which may include;
Taking responsibility for the verification testing for an assay or version of the LumiraDx instrument.
Developing or improving new departmental processes.
Planning and executing appropriate experiments for the purpose of developing verification testing methods and assessing assay performance in line with design inputs.
Overseeing clinical sample testing for the department
Use statistical methods to design and analyse experiments and make the appropriate scientific conclusions and define next steps required.
Solve problems encountered during assay development innovatively and independently.
Create and maintain quality records for the purpose of assessing and improving assay methodologies and documenting experiments in line with the requirements of the LumiraDx quality management system
Technically reviewing change controls and peer reviewing laboratory notebooks.
Raising, investigating and closing non-conformances to agreed timelines.
Completing COSHH assessments as and when required.
Ensuring you are trained on all appropriate procedures and training new personnel if and when required.
Ensuring you work in conjunction with the quality policy and objectives.
Help less experienced members of the verification team to carry out experiments effectively.
Writing and updating lab and project related procedures and documents.
Lead cross functional engagement in solving complex problems encountered during product development.
Managing and developing a team of up to five technical staff within the Verification department.
About You :
We are looking for an experienced Verification Scientist with the following attributes :
Essential skills :
Line management experience.
Degree in a relevant scientific discipline
Track record of Verification and Validation testing for In Vitro Diagnostics or Medical Devices or similar regulated industry
Knowledge of product and process validation and verification.
Knowledge and understanding of factors which drive assay performance
High levels of skills in problem solving and innovation
Strong organisational skills
Ability to write clear and concise protocols for complex verification testing